[Federal Register Volume 74, Number 202 (Wednesday, October 21, 2009)]
[Notices]
[Pages 54040-54042]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-25356]
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ENVIRONMENTAL PROTECTION AGENCY
[FRL-8970-7; Docket ID No. EPA-HQ-ORD-2009-0132]
Integrated Risk Information System (IRIS) Update Project;
Announcement of 2009/2010 Agenda
AGENCY: Environmental Protection Agency.
ACTION: Notice of 2009/2010 IRIS Update Project and request for
information.
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SUMMARY: The U.S. Environmental Protection Agency (EPA) is announcing
the establishment of the Integrated Risk Information System (IRIS)
Update Project. The purpose of the IRIS Update Project is to revisit a
portion of the dose-response assessment values with a posting date on
the IRIS database that is more than 10 years old. IRIS is an EPA data
base containing human health risk information on possible adverse
health effects that may result from chronic or long-term exposures to
chemical substances found in the environment. This Federal Register
notice (FRN) also announces the IRIS Update Project's 2009/2010 agenda
and requests submission of new and relevant scientific information on
health effects for the identified assessments listed in the Project's
2009/2010 agenda.
While EPA is not expressly soliciting comments on this notice, the
Agency will accept information related to the substances included
herein. Please submit any information in accordance with the
instructions provided below.
DATES: Information must be submitted within 60 days of the publication
of this notice. The 60-day period begins October 21, 2009 and ends
December 21, 2009. Technical comments should be in writing and must be
received by EPA by December 21, 2009.
ADDRESSES: Comments may be submitted electronically via http://www.regulations.gov, by mail, by facsimile, or by hand delivery/
courier. Please follow the detailed instructions provided in the
SUPPLEMENTARY INFORMATION section of this notice.
FOR FURTHER INFORMATION CONTACT: For information on the public comment
period, contact the Office of Environmental Information Docket;
telephone: 202-566-1752; facsimile: 202-566-1753; or e-mail:
ORD.Docket@epa.gov. For information on the IRIS Update project, contact
Dr. Chon Shoaf, National Center for Environmental Assessment, (mail
code: B243-01), Office of Research and Development, U.S. Environmental
Protection Agency, RTP, NC 27711; telephone: 919-541-4155, facsimile:
919-541-1818; or e-mail: shoaf.chon@epa.gov.
SUPPLEMENTARY INFORMATION:
Background
The intent of the IRIS Update Project is to revisit all dose-
response assessment toxicity values such as oral reference doses
(RfDs), inhalation reference concentrations (RfCs), cancer oral slope
factors, and cancer inhalation unit risks in IRIS with a posting or
entry date more than 10 years old.
IRIS is a database of human health effects that may result from
chronic exposure to various chemical substances or other contaminants
found in the environment. IRIS currently provides information on health
effects associated with more than 500 chemical substances. The database
includes substance-specific summaries of qualitative and quantitative
health information in support of the first two steps of the risk
assessment process, i.e., hazard identification and dose-response
evaluation. Also, IRIS has included detailed Toxicological Reviews as
support documents since 1995. Government and private entities use IRIS,
combined with specific exposure information, to help characterize
public health risks of chemical substances in a site-specific situation
and thereby support risk management decisions designed to protect
public health. IRIS is prepared and maintained by the EPA's National
Center for Environmental Assessment within the Office of Research and
Development.
While separate from the regular IRIS program, the IRIS Update
Project draws on the IRIS data base as the source of human health
assessments in need of update. The purpose of the IRIS Update Project
is to replace existing IRIS assessment toxicity values and their
supporting information that are more than 10 years old with new and
relevant scientific information on health effects. As updated
assessments are completed as part of this process, they will be posted
on IRIS.
The IRIS Update Project defines ``assessment'' as an individual
IRIS toxicity value along with its supporting information. For example,
the Project identifies the values for an oral RfD, an inhalation RfC,
and a cancer evaluation along with supporting information, as three
assessments. Certain IRIS entries, however, may contain values that do
not qualify for the update process. For example, a particular substance
with an oral RfD derived 15 years ago would qualify for the update
process, but a
[[Page 54041]]
cancer evaluation derived 3 years ago for that same substance would not
qualify. Also, the IRIS Update Project will not address any substances
or toxicity values that are not currently on IRIS.
The IRIS Update Project's process consists of: (1) Publishing an
annual Federal Register notice announcing EPA's IRIS Update Project
agenda and calling for scientific information from the public regarding
assessments on the agenda; (2) conducting a comprehensive search of the
current scientific literature on each assessment; (3) developing draft
health assessment documents using state of the science methods and
guidelines; (4) conducting a combined simultaneous review of the draft
assessment documents by EPA and other Federal Agencies via the Federal
Standing Science Committee; (5) soliciting public comments on draft
assessments, followed by independent external peer review under the
Federal Advisory Committee Act (FACA); (6) preparing final IRIS
assessments that reflect public comments and independent expert review;
and (7) replacing the existing assessments with the final updated IRIS
assessments on the IRIS data base (http://www.epa.gov/iris).
This FRN describes only the first two steps of the update process.
The literature and new data obtained in response to this FRN will be
evaluated as to whether or not the assessment(s) can be completed
within the resources and capacity of the IRIS Update Project. A
subsequent FRN will announce the assessments proceeding through steps 3
through 6.
IRIS Update Agenda
Each year, EPA will develop a priority list of chemicals and an
agenda of assessments to undergo the IRIS update process. EPA uses a
variety of criteria to prioritize which assessments will be included on
the agenda. General priority criteria include: Consideration of
potential public health impact; EPA statutory, regulatory, or program-
specific implementation needs; interest to other governmental agencies
or the public; and availability of other scientific assessment
documents that could serve as a basis for an update of an IRIS
assessment. Specific priority criteria will take into consideration the
frequency of occurrence in National Priority List (NPL) waste sites,
occurrence as hazardous air pollutants used in residual risk
assessments, and potential as a water pollutant based on the chemical
contaminants list (CCL). The Update Project will strive to prevent
duplication of effort with other assessment organizations. Thus,
assessments currently on IRIS Track or assessments for pesticides that
are available elsewhere within EPA have been eliminated from
consideration for the IRIS Update Project.
EPA is soliciting public involvement in the process for those
assessments on the IRIS Update Project's 2009/2010 agenda. While EPA
conducts a thorough literature search for each assessment, there may be
unpublished studies or other primary technical sources that are not
available through the open literature. EPA would appreciate receiving
scientific information from the public during the information gathering
stage for the assessments listed in this notice. Interested persons
should provide scientific analyses, studies, and other pertinent
scientific information. This notice provides instructions for
submitting scientific information to EPA pertinent to updating these
assessments.
Assessments on 2009/2010 Agenda
The following IRIS assessments have been selected for inclusion in
the IRIS Update Project agenda and are currently underway. The IRIS
posting dates are provided to aid the submitter in determining whether
information may have already been considered in the current online IRIS
assessment.
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Assessment (IRIS
Substance name posting date) CASRN
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barium.............................. cancer (1998)..... 7440-39-3
bromoform........................... RfD (1989), cancer 75-25-2
(1990).
carbon disulfide.................... RfD (1990), RfC 75-15-0
(1995).
chlorobenzene....................... RfD (1989), cancer 108-90-7
(1990).
2-chlorophenol...................... RfD (1988)........ 95-57-8
o-cresol............................ RfD (1988), cancer 95-48-7
(1990).
cumene.............................. RfD (1997), RfC 98-82-8
(1997), cancer
(1997).
1,1-dichloroethane.................. cancer (1990)..... 75-34-3
2,4-dimethylphenol.................. RfD (1990)........ 105-67-9
2,4-dinitrophenol................... RfD (1991)........ 51-28-5
2,4-dinitrotoluene.................. RfD (1992)........ 121-14-2
hexachlorobenzene................... RfD (1988), cancer 118-74-1
(1991).
selenium............................ RfD (1991), cancer 7782-49-2
(1991).
1,1,2-trichloroethane............... RfD (1988), cancer 79-00-5
(1994).
2,4,6-trichlorophenol............... cancer (1990)..... 88-06-2
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Information Requested on IRIS Update Assessments for 2009/2010
EPA is currently conducting literature searches for these
assessments. The overall purpose of these literature searches is to
identify new and relevant information for each assessment. Relevant
information is that which improves the scientific understanding of the
agent's toxicity in humans; new information is relevant information
that is not included in the current online IRIS assessment. Based on
the results of the literature searches and the information submitted in
response to this announcement, EPA will evaluate assessments to
determine whether they can be accommodated within the scope and
resources of the IRIS Update Project.
With this IRIS update agenda announcement, EPA is actively
soliciting information from the public at the beginning of the
assessment update process. As literature searches are completed, they
will be posted at http://www.regulations.gov for public inspection.
General Information
How To Submit Technical Comments to the Docket at http://www.regulations.gov
Submit your comments, identified by Docket ID No. EPA-HQ-ORD 2009-
0132, by one of the following methods:
http://www.regulations.gov: Follow the on-line
instructions for submitting comments.
[[Page 54042]]
E-mail: ORD.Docket@epa.gov.
Fax: 202-566-1753.
Mail: Office of Environmental Information (OEI) Docket
(Mail Code: 2822T), U.S. Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460. The phone number is 202-
566-1752.
Hand Delivery: The OEI Docket is located in the EPA
Headquarters Docket Center, Room 3334 EPA West Building, 1301
Constitution Ave., NW., Washington, DC. The EPA Docket Center Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is 202-566-1744. Such deliveries are only accepted during
the docket's normal hours of operation, and special arrangements should
be made for deliveries of boxed information.
If you provide comments by mail or hand delivery, please submit an
original and three copies of the comments. For attachments, provide an
index, number pages consecutively with the comments, and submit an
unbound original and three copies.
Instructions: Direct your comments to Docket ID No. EPA-HQ-ORD-
2009-0132. Please ensure that your comments are submitted within the
specified comment period. Comments received after the closing date will
be marked ``late,'' and may only be considered if time permits. It is
EPA's policy to include all comments it receives in the public docket
without change and to make the comments available online at http://www.regulations.gov, including any personal information provided,
unless a comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit information that you consider to
be CBI or otherwise protected through http://www.regulations.gov or e-
mail. The http://www.regulations.gov Web site is an ``anonymous
access'' system, which means EPA will not know your identity or contact
information unless you provide it in the body of your comment. If you
send an e-mail comment directly to EPA without going through http://www.regulations.gov, your e-mail address will be automatically captured
and included as part of the comment that is placed in the public docket
and made available on the Internet. If you submit an electronic
comment, EPA recommends that you include your name and other contact
information in the body of your comment and with any disk or CD-ROM you
submit. If EPA cannot read your comment due to technical difficulties
and cannot contact you for clarification, EPA may not be able to
consider your comment. Electronic files should avoid the use of special
characters, any form of encryption, and be free of any defects or
viruses. For additional information about EPA's public docket visit the
EPA Docket Center homepage at http://www.epa.gov/epahome/dockets.htm.
Docket: Documents in the docket are listed in the http://www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other materials,
such as copyrighted material, are publicly available only in hard copy.
Publicly available docket materials are available either electronically
in http://www.regulations.gov or in hard copy at the OEI Docket in the
EPA Headquarters Docket Center.
Dated: October 13, 2009.
Rebecca Clark,
Acting Director, National Center for Environmental Assessment.
[FR Doc. E9-25356 Filed 10-20-09; 8:45 am]
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